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Clinical Solutions Analyst

Zachary Piper Solutions, LLC

Remote

Full-time

Piper Companies is seeking a Clinical Solutions Analyst who understands software and computerized systems in the clinical trial process. The Clinical Solutions Analyst will be remote , supporting a Raleigh, NC headquarters. Requirements for the Clinical Solutions Analyst include: - Collaborate with relevant business users (clinical project managers, clinical research associates, data managers, etc) to understand solution requirements, develop and document business processes, and provide ongoing

Regulatory Solutions Architect

INGENworks

Remote

Contract

Regulatory Solutions Architect Location: RemoteDuration: Long Term Required Qualifications:Bachelor s or Master s degree in Computer Science, Regulatory Affairs, Life Sciences, or a related field.7+ years of experience in Regulatory IT or Regulatory Affairs, including 3+ years as an Architect or Lead.Proven experience working with Commercial Regulatory Affairs systems (e.g., labeling, promotional compliance, Veeva PromoMats, MedComms).In-depth knowledge of regulatory requirements in US, EU, and

Distribution Quality Manager

Stellent IT LLC

Lexington, Massachusetts, USA

Contract, Third Party

Distribution Quality Manager Location: Lexington, Massachusetts(Hybrid) JD: Purpose: The role is responsible for quality support of US Domestic Distribution Logistics (USDDL) which includes US and Puerto Rico. This includes quality support for Patient Assistance Program (PAP), Access to Medicines (ATM), and Physician Sample Program in the US. The role is also responsible for Quality support of US Global Distribution Logisitics (USGDL) in regards to exports from the US to other markets. The role

CSV Engineer

Katalyst Healthcares and Lifesciences

Elwood, Kansas, USA

Full-time

Responsibilities: Provide Quality Assurance oversight for the execution, commissioning, qualification, and validation activities for major projects. This may include, but is not limited to; Factory Acceptance Testing, construction oversight, execution of onsite commissioning and qualification activities, support for process validation, etc. Ensure execution of capital projects consider USDA and EMA regulatory and quality requirements. Review relevant documentation including user requirement spec

CSV Engineer

Katalyst Healthcares and Lifesciences

Massachusetts, USA

Full-time

Job Overview: Our client seeking an experienced CSV / IT GxP Consultant. This role will focus on ensuring the alignment of internal policies with federal and state regulations, improving our Computer System Validation (CSV) processes, and enhancing third-party vendor compliance. The position will also involve developing and implementing SOPs, as well as managing data privacy and retention policies. The ideal candidate will have experience in GxP regulations and a strong understanding of IT proce

Validation Engineer

Katalyst Healthcares and Lifesciences

King of Prussia, Pennsylvania, USA

Full-time

Responsibilities: Designing and executing validation including support of computer system validation protocols to ensure consistency of data production and compliance with client's quality standards (including internal ISPE referenced guidelines, client procedures, and 21 Code of Federal Regulations Part 2XX and 8XX level standards which apply to the equipment and product being validated). Ensuring product and process development activities have all necessary validation and supporting justifica

Software Quality Engineer

Katalyst Healthcares and Lifesciences

Irving, Texas, USA

Full-time

Responsibilities: Review and Approval of software lifecycle (SLC) Deliverables for Regulated applications; Risk Classifications, Requirements, Config/Design Specs, IQ, OQ, PQ, Trace Matrix, Summary Reports etc. Collaborate with the cross-functional teams to build compliance capabilities to assure the quality of the deliverables and ensure the business needs are met. Review of CAPAs, Change Controls and Defects for GxP applications. Working with Global teams and providing audit support. Work

Research Associate, In Vivo Pharmacology

Zachary Piper Solutions, LLC

Durham, North Carolina, USA

Full-time

Seeking a Research Associate, In Vivo Pharmacology for an onsite position in Durham, North Carolina. The Research Associate will play a crucial role in supporting research efforts, including processing tissue samples, managing mouse colonies, and assisting with in vivo study activities. This lab-based role requires strong attention to detail, excellent organizational skills, and the ability to collaborate in a fast-paced environment. Responsibilities of the Research Associate, In Vivo Pharmacol

Validation Engineer

Katalyst Healthcares and Lifesciences

Allendale, New Jersey, USA

Full-time

Responsibilities: Work under the direction of the Validation Lead and/or function as the validation lead for a project team. The Validation Engineer will be required to support multiple projects simultaneously. Develop and execute IQ, OQ, and PQ protocols for products, processes, facilities, software, and equipment within the facility. Experience authoring Validation Plan documents, User Requirements, Traceability Matrix, and Validation Summary Reports. Write reports summarizing results and s

Validation Lead, SAP S4 HANA

Katalyst Healthcares and Lifesciences

Remote or New Jersey, USA

Full-time

Responsibilities: Lead the validation team in a strategic, risk-based approach that optimizes legacy Computer System documentation, CSA strategies and strong SAP ECC->S/4 HANAconversion knowledge to successfully deliver a validated system meeting all project requirements. Review, approval, and processing of Computer System Lifecycle deliverables including: User Requirements, Specifications, Test Plans, IQ, OQ, PQ Test Scripts, User Guides. Fostering of effective relationships with implementati

Product Lead, Omnichannel & Next Gen Engagements-Data platforms

Takeda pharmaceutical

Boston, Massachusetts, USA

Full-time

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description OBJECTIVES At Takeda, we share the belief that the speed of change will never be as slow as it is today. Takeda is uniquely position

Software Engineer - Java

Veeva Systems

Raleigh, North Carolina, USA

Full-time

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company - we made history in 2021 by becoming a public benefit corporation

Sr. Quality Assurance Engineer - Medical Device Regulatory

Motion Recruitment Partners, LLC

Oklahoma City, Oklahoma, USA

Full-time

Our client is redefining what's possible in medical technology. Their team is dedicated to developing innovative medical devices that improve patient outcomes and set new standards for safety, efficacy, and usability. They are seeking a highly experienced and detail-oriented?Senior Quality Assurance Engineer?to join their growing Quality team and play a key role in ensuring compliance across our product lifecycle. As a Senior Quality Assurance Engineer, you will be a subject matter expert in reg

Quality Systems Specialist II - Data Integrity

Civica Rx

Petersburg, Virginia, USA

Full-time

About Civica Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders. Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran's Affairs

Manager/Sr. Manager - Health Data Partnerships

Veeva Systems

New York, New York, USA

Full-time

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company - we made history in 2021 by becoming a public benefit corporation

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

Libertyville, Illinois, USA

Full-time

Responsibilities: The Manufacturing IT Systems Quality & Compliance Specialist- Cell Therapy Manufacturing Systems supports the successful operation of manufacturing and business functions at Libertyville site through interaction with internal team members, peer and higher-level customers as well as external service providers. The individual is responsible for the development of and adherence to system governance procedures. The individual supports multiple IT projects/systems and ongoing work a

Data Consultant - OpenData Commercial

Veeva Systems

Boston, Massachusetts, USA

Full-time

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company - we made history in 2021 by becoming a public benefit corporation

Engineering Manager (West Coast)

Veeva Systems

Pleasanton, California, USA

Full-time

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company - we made history in 2021 by becoming a public benefit corporation

RTSM Product Support Engineer

Veeva Systems

Boston, Massachusetts, USA

Full-time

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company - we made history in 2021 by becoming a public benefit corporation

Associate Director - Field Deployment and Incentive Compensation

Sanofi EU

Cambridge, Massachusetts, USA

Full-time

Job title: Associate Director, Field Deployment and Incentive Compensation Location: Cambridge, MA Morristown, NJ About the Job Ready to push the limits of what's possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world. The Associate Director, Field Execution is responsible for overseeing the execution and delivery of strategic deliverables in Field Design & Depl